ATE363541T1 - METHOD FOR PRODUCING A DESIRED PROFILE OF ERYTHROPOIETIN GLYCO ISOFORMS - Google Patents

METHOD FOR PRODUCING A DESIRED PROFILE OF ERYTHROPOIETIN GLYCO ISOFORMS

Info

Publication number
ATE363541T1
ATE363541T1 AT02716973T AT02716973T ATE363541T1 AT E363541 T1 ATE363541 T1 AT E363541T1 AT 02716973 T AT02716973 T AT 02716973T AT 02716973 T AT02716973 T AT 02716973T AT E363541 T1 ATE363541 T1 AT E363541T1
Authority
AT
Austria
Prior art keywords
epo
erythropoietin
isoforms
glycol
desired profile
Prior art date
Application number
AT02716973T
Other languages
German (de)
Inventor
Monica Svetina
Jelka Svetek
Mateja Gantar-Ksela
Matjaz Brinc
Andrej Francky
Original Assignee
Lek Tovarna Farmacevtskih
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Lek Tovarna Farmacevtskih filed Critical Lek Tovarna Farmacevtskih
Application granted granted Critical
Publication of ATE363541T1 publication Critical patent/ATE363541T1/en

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/475—Growth factors; Growth regulators
    • C07K14/505—Erythropoietin [EPO]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Toxicology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Abstract

The present invention provides a process for the production of erythropoietin (EPO) with high purity and with a desired profile of EPO glycol-isoforms by using a combination of specific chromatographic steps in such a manner that the starting EPO glycol-isoform profile is changed or modified. The applied chromatographic steps includes at least (a) dye affinity chromatography, and (b) hydrophobic chromatography and/or (c) anion-exchange chromatography. In a preferred embodiment, the process further includes (d) gel filtration chromatography. The present invention also provides a process for the determination of erythropoietin (EPO) glycol-isoform profile in an EPO containing composition.
AT02716973T 2002-03-26 2002-03-26 METHOD FOR PRODUCING A DESIRED PROFILE OF ERYTHROPOIETIN GLYCO ISOFORMS ATE363541T1 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IB2002/000971 WO2003080852A1 (en) 2002-03-26 2002-03-26 Process for the preparation of a desired erythropoietin glyco-isoform profile

Publications (1)

Publication Number Publication Date
ATE363541T1 true ATE363541T1 (en) 2007-06-15

Family

ID=28053152

Family Applications (1)

Application Number Title Priority Date Filing Date
AT02716973T ATE363541T1 (en) 2002-03-26 2002-03-26 METHOD FOR PRODUCING A DESIRED PROFILE OF ERYTHROPOIETIN GLYCO ISOFORMS

Country Status (8)

Country Link
US (1) US20050153879A1 (en)
EP (1) EP1492878B1 (en)
JP (1) JP4109204B2 (en)
AT (1) ATE363541T1 (en)
AU (1) AU2002247896A1 (en)
DE (1) DE60220451T2 (en)
SI (1) SI1492878T1 (en)
WO (1) WO2003080852A1 (en)

Families Citing this family (99)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102004027816A1 (en) 2004-06-08 2006-01-05 Bioceuticals Arzneimittel Ag Process for the purification of erythropoietin
US7566401B2 (en) * 2005-10-03 2009-07-28 Kelm Mark A Process for separating and isolating xanthines, individual polar protic monomers, and polar protic oligomers
AR053416A1 (en) 2005-11-10 2007-05-09 Protech Pharma S A COMBINATION OF GLICOISOFORMS FOR THE TREATMENT OR PREVENTION OF SEPTICEMIA, TRANSGENIC CELLULAR LINE PRODUCING ERYTHROPOYETINE GLICOFORMES, PHARMACEUTICAL COMPOSITION THAT INCLUDES SUCH COMBINATION, PROCEDURES TO OBTAIN THE CELLULAR PROCEDURE
AR058568A1 (en) 2005-12-20 2008-02-13 Bristol Myers Squibb Co METHODS TO PRODUCE A COMPOSITION WITH CTLA4-IG MOLECULES FROM A CROP MEANS
PL2253644T3 (en) 2005-12-20 2014-04-30 Bristol Myers Squibb Co Compositions and methods for producing a composition
AR065083A1 (en) * 2007-02-02 2009-05-13 Amgen Inc HEPCIDINE, HEPCIDINE ANTAGONISTS AND METHODS OF USE
AU2008304111B2 (en) * 2007-09-27 2014-04-24 Amgen Inc. Pharmaceutical formulations
EP3381445B1 (en) 2007-11-15 2023-10-25 Amgen Inc. Aqueous formulation of antibody stablised by antioxidants for parenteral administration
AU2009206306B2 (en) 2008-01-25 2013-06-06 Amgen Inc. Ferroportin antibodies and methods of use
JP2011519279A (en) 2008-05-01 2011-07-07 アムジエン・インコーポレーテツド Anti-hepcidin antibodies and methods of use
EP2334699B1 (en) 2008-09-23 2013-09-11 F. Hoffmann-La Roche AG Purification of erythropoietin
EP2349332B1 (en) 2008-11-13 2019-10-23 The General Hospital Corporation Methods and compositions for regulating iron homeostasis by modulation bmp-6
DE102008054716A1 (en) * 2008-12-16 2010-06-17 Evonik Degussa Gmbh In-process control in a process for the production of EPO
EA022396B1 (en) * 2009-09-23 2015-12-30 Ратиофарм Гмбх Process for the purification of recombinant human erythropoietin (epo), epo thus purified and pharmaceutical compositions comprising same
MX344382B (en) 2009-10-23 2016-12-14 Amgen Inc * Vial adapter and system.
ES2545411T5 (en) 2010-06-07 2024-04-05 Amgen Inc drug delivery device
AU2011329053A1 (en) * 2010-11-15 2013-06-06 Biogen Inc. Enrichment and concentration of select product isoforms by overloaded bind and elute chromatography
CA2831100C (en) 2011-03-31 2020-02-18 Mark Dominis Holt Vial adapter and system
CA3021845C (en) 2011-04-20 2022-03-29 Amgen Inc. Autoinjector apparatus
LT3045187T (en) 2011-10-14 2019-07-10 Amgen Inc. Injector and method of assembly
SI3081249T1 (en) 2012-11-21 2021-03-31 Amgen Inc. Drug delivery device
CN105142695B (en) 2013-03-15 2020-06-02 安进公司 Body contour adaptable autoinjector device
EP2968503B1 (en) 2013-03-15 2018-08-15 Intrinsic LifeSciences LLC Anti-hepcidin antibodies and uses thereof
EP2968775B1 (en) 2013-03-15 2019-12-18 Amgen Inc. Drug cassette, autoinjector, and autoinjector system
TWI580451B (en) 2013-03-15 2017-05-01 安美基公司 Cassette for an injector and method of using an autoinjector apparatus having an autoinjector and a cassette
SG11201507878SA (en) 2013-03-22 2015-10-29 Amgen Inc Injector and method of assembly
EP3060281B1 (en) 2013-10-24 2019-01-30 Amgen Inc. Drug delivery system with temperature-sensitive control
EP3421066B1 (en) 2013-10-24 2021-03-03 Amgen Inc. Injector and method of assembly
WO2015119906A1 (en) 2014-02-05 2015-08-13 Amgen Inc. Drug delivery system with electromagnetic field generator
JP6640113B2 (en) 2014-05-07 2020-02-05 アムジエン・インコーポレーテツド Auto-injector with impact reducing element
CN112237662B (en) 2014-06-03 2022-10-21 安姆根有限公司 Drug delivery system and method of use
WO2016049036A1 (en) 2014-09-22 2016-03-31 Intrinsic Lifesciences Llc Humanized anti-hepcidin antibodies and uses thereof
WO2016061220A2 (en) 2014-10-14 2016-04-21 Amgen Inc. Drug injection device with visual and audio indicators
US9908932B2 (en) 2014-10-15 2018-03-06 Alexion Pharmaceuticals, Inc. Methods of shifting an isoelectric profile of a protein product and uses thereof
US11357916B2 (en) 2014-12-19 2022-06-14 Amgen Inc. Drug delivery device with live button or user interface field
EP3848072A1 (en) 2014-12-19 2021-07-14 Amgen Inc. Drug delivery device with proximity sensor
CA2976935C (en) 2015-02-17 2020-03-10 Amgen Inc. Drug delivery device with vacuum assisted securement and/or feedback
WO2016138434A1 (en) 2015-02-27 2016-09-01 Amgen Inc. Drug delivery device having a needle guard mechanism with a tunable threshold of resistance to needle guard movement
WO2017039786A1 (en) 2015-09-02 2017-03-09 Amgen Inc. Syringe assembly adapter for a syringe
ES2755717T3 (en) 2015-12-09 2020-04-23 Amgen Inc Autoinjector with signaling cap
US11154661B2 (en) 2016-01-06 2021-10-26 Amgen Inc. Auto-injector with signaling electronics
US11200298B2 (en) 2016-03-15 2021-12-14 Amgen Inc. Reducing probability of glass breakage in drug delivery devices
US11541168B2 (en) 2016-04-29 2023-01-03 Amgen Inc. Drug delivery device with messaging label
WO2017192287A1 (en) 2016-05-02 2017-11-09 Amgen Inc. Syringe adapter and guide for filling an on-body injector
EP3455142B1 (en) 2016-05-13 2023-08-09 Amgen Inc. Vial sleeve assembly
US11238150B2 (en) 2016-05-16 2022-02-01 Amgen Inc. Data encryption in medical devices with limited computational capability
US11541176B2 (en) 2016-06-03 2023-01-03 Amgen Inc. Impact testing apparatuses and methods for drug delivery devices
WO2018004842A1 (en) 2016-07-01 2018-01-04 Amgen Inc. Drug delivery device having minimized risk of component fracture upon impact events
WO2018034784A1 (en) 2016-08-17 2018-02-22 Amgen Inc. Drug delivery device with placement detection
US20200261643A1 (en) 2016-10-25 2020-08-20 Amgen Inc. On-body injector
WO2018136398A1 (en) 2017-01-17 2018-07-26 Amgen Inc. Injection devices and related methods of use and assembly
US11752258B2 (en) 2017-02-17 2023-09-12 Amgen Inc. Drug delivery device with sterile fluid flowpath and related method of assembly
US11369736B2 (en) 2017-02-17 2022-06-28 Amgen Inc. Cannula insertion and retraction mechanisms
CA3050927A1 (en) 2017-03-06 2018-09-13 Brian Stonecipher Drug delivery device with activation prevention feature
KR102627069B1 (en) 2017-03-07 2024-01-18 암겐 인코포레이티드 Needle insertion due to overpressure
EP3592404A1 (en) 2017-03-09 2020-01-15 Amgen Inc. Insertion mechanism for drug delivery device
EP3570871B1 (en) 2017-03-20 2020-11-18 H. Hoffnabb-La Roche Ag Method for in vitro glycoengineering of an erythropoiesis stimulating protein
KR102651078B1 (en) 2017-03-28 2024-03-22 암겐 인코포레이티드 Plunger rod and syringe assembly system and method
US11590294B2 (en) 2017-06-08 2023-02-28 Amgen Inc. Syringe assembly for a drug delivery device and method of assembly
JP7200134B2 (en) 2017-06-08 2023-01-06 アムジエン・インコーポレーテツド Torque driven drug delivery device
JP7195276B2 (en) 2017-06-22 2022-12-23 アムジエン・インコーポレーテツド Collision/shock reduction due to device activation
MA49461A (en) 2017-06-23 2020-04-29 Amgen Inc ELECTRONIC DRUG DELIVERY DEVICE INCLUDING A CAP ACTIVATED BY A SWITCH ASSEMBLY
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EP3655063A1 (en) 2017-07-21 2020-05-27 Amgen Inc. Gas permeable sealing member for drug container and methods of assembly
US11484648B2 (en) 2017-07-25 2022-11-01 Amgen Inc. Drug delivery device with container access system and related method of assembly
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WO2019036181A1 (en) 2017-08-18 2019-02-21 Amgen Inc. Wearable injector with sterile adhesive patch
US11103636B2 (en) 2017-08-22 2021-08-31 Amgen Inc. Needle insertion mechanism for drug delivery device
WO2019070472A1 (en) 2017-10-04 2019-04-11 Amgen Inc. Flow adapter for drug delivery device
CN111132711B (en) 2017-10-06 2022-07-01 安进公司 Drug delivery device with interlocking components and related assembly methods
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WO2019090086A1 (en) 2017-11-03 2019-05-09 Amgen Inc. Systems and approaches for sterilizing a drug delivery device
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US20200261648A1 (en) 2017-11-06 2020-08-20 Amgen Inc. Drug delivery device with placement and flow sensing
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AU2018368338B2 (en) 2017-11-16 2024-07-25 Amgen Inc. Autoinjector with stall and end point detection
US10835685B2 (en) 2018-05-30 2020-11-17 Amgen Inc. Thermal spring release mechanism for a drug delivery device
US11083840B2 (en) 2018-06-01 2021-08-10 Amgen Inc. Modular fluid path assemblies for drug delivery devices
WO2020023220A1 (en) 2018-07-24 2020-01-30 Amgen Inc. Hybrid drug delivery devices with tacky skin attachment portion and related method of preparation
CA3103681A1 (en) 2018-07-24 2020-01-30 Amgen Inc. Delivery devices for administering drugs
WO2020023451A1 (en) 2018-07-24 2020-01-30 Amgen Inc. Delivery devices for administering drugs
WO2020023336A1 (en) 2018-07-24 2020-01-30 Amgen Inc. Hybrid drug delivery devices with grip portion
EP3829692A1 (en) 2018-07-31 2021-06-09 Amgen Inc. Fluid path assembly for a drug delivery device
EP3856284A1 (en) 2018-09-24 2021-08-04 Amgen Inc. Interventional dosing systems and methods
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MX2021003492A (en) 2018-10-02 2021-06-18 Amgen Inc INJECTION SYSTEMS FOR THE ADMINISTRATION OF DRUGS WITH TRANSMISSION OF INTERNAL FORCE.
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AU2019359801B2 (en) 2018-10-15 2025-01-02 Amgen Inc. Platform assembly process for drug delivery device
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MA54057A (en) 2018-11-01 2022-02-09 Amgen Inc DRUG DELIVERY ELEMENT PARTIAL RETRACTION DRUG DELIVERY DEVICES
ES3010833T3 (en) 2018-11-01 2025-04-04 Amgen Inc Drug delivery devices with partial drug delivery member retraction
TWI831847B (en) 2018-11-01 2024-02-11 美商安進公司 Drug delivery devices with partial needle retraction and methods for operating the same
AU2020263289B2 (en) 2019-04-24 2025-05-22 Amgen Inc. Syringe sterilization verification assemblies and methods
MX2022002149A (en) 2019-08-23 2022-03-17 Amgen Inc Drug delivery device with configurable needle shield engagement components and related methods.
MX2023013640A (en) * 2021-05-21 2023-11-30 Amgen Inc Method of optimizing a filling recipe for a drug container.
KR20250099137A (en) 2022-11-02 2025-07-01 에프. 호프만-라 로슈 아게 Method for producing a glycoprotein composition
WO2026030152A1 (en) 2024-07-29 2026-02-05 Amgen Inc. System and method for assessing transferability of a fill recipe

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL118201A (en) * 1995-05-11 2004-12-15 Roche Diagnostics Gmbh Preparation comprising a protein with human erythropoietin activity which is free of serum and non-recombinant mammalian protein and process for the preparation thereof
TR200001580T2 (en) * 1997-12-03 2000-12-21 Roche Diagnostics Gmbh Erythropoietin with high specific activity
EP0984062A1 (en) * 1998-09-04 2000-03-08 Cytos Biotechnology AG Production of human erythropoietin
CN1596268A (en) * 2001-11-28 2005-03-16 桑多斯有限公司 Chromatographic purification of recombinant human erythropoietin

Also Published As

Publication number Publication date
SI1492878T1 (en) 2007-12-31
AU2002247896A1 (en) 2003-10-08
DE60220451D1 (en) 2007-07-12
JP2005520550A (en) 2005-07-14
EP1492878B1 (en) 2007-05-30
WO2003080852A1 (en) 2003-10-02
DE60220451T2 (en) 2008-01-24
US20050153879A1 (en) 2005-07-14
JP4109204B2 (en) 2008-07-02
EP1492878A1 (en) 2005-01-05

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